Archive Coordinator

Job Location
US-PA-Pittsburgh

Shift

Full-time/Regular

Type

Regular Full-Time

Overview

ERT is looking to hire an Archive Coordinator. In this role, you will be responsible for compiling documents and data files from each of ePRO clinical trials into a complete study archive and delivering each study archive to clients. Our clients are pharmaceutical and biotech companies that sponsor clinical trials and sites that participate in the trials.

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.

Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Work with Archive Team, Client Services, Technical Operations and others as needed to complete the document set for each clinical trial archive:

Locate and organize trial documents

Request completion of missing or incomplete documents

Verify approved document versions and signatures

Obtain missing signatures as needed

Review documents and data for completeness

Take ownership for and follow up to closure on all document action items.

Complete Archive Production tasks:

Burn CDs for sponsor and site archives

Packaging and shipping

OTHER DUTIES AND RESPONSIBILITIES:

Other duties as assigned by management

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.

Qualifications

BS, BA or equivalent preferred but not required.

A commitment to meet deadlines with a keen focus on details.

Ability to manage multiple tasks simultaneously.

Ability to coordinate deliverables from both local and remote offices.

Comfortable using computers for day to day operations and ability to quickly learn and use sophisticated computer programs.

Comfortable working in a fast-paced, team-focused environment with minimal supervision.

Good verbal and written communication skills.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.